Reviews PegIntron, Rebetol Combo Pack


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PegIntron, Rebetol Combo Pack Drug Description
Peglntron™ REDIPEN® Single-dose Delivery System
(peginterferon alfa-2b) and
REBETOL®
(ribavirin, USP) Capsules

Significant teratogenic and/or embryocidal effects have been demonstrated
in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose
half-life of 12 days, and so it may persist in nonplasma compartments for
as long as 6 months. Therefore, REBETOL® therapy is contraindicated in
women who are pregnant and in the male partners of women who are pregnant.
Extreme care must be taken to avoid pregnancy during therapy and for 6 months
after completion of treatment in both female patients and in female partners
of male patients who are taking REBETOL® therapy. At least two reliable
forms of effective contraception must be utilized during treatment and during
the 6-month posttreatment follow-up period. (See CONTRAINDICATIONS,
WARNINGS, PRECAUTIONS -
lnformation for Patients and Pregnancy
Category X.)
The primary toxicity of ribavirin is hemolytic anemia. The anemia associated
with REBETOL® therapy may result in a worsening of cardiac disease that
has led to fatal and nonfatal myocardial infarctions. Patients with a history
of significant or unstable cardiac disease should not be treated with REBETOL®.
(See WARNINGS, ADVERSE
REACTIONS, and DOSAGE AND ADMINISTRATION.) Alpha interferons, including Peglntron™, may cause or aggravate fatal
or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious
disorders. Patients should be monitored closely with periodic clinical and
laboratory evaluations. Patients with persistently severe or worsening signs
or symptoms of these conditions should be withdrawn from therapy. In many
but not all cases these disorders resolve after stopping Peglntron™
therapy. (See WARNINGS, ADVERSE
REACTIONS.)

DRUG DESCRIPTION
Peglntron™/REBETOL® Combo Pack contains Peglntron™ REDIPEN® Single-dose Delivery System (peginterferon alfa-2b) and REBETOL® (ribavirin) capsules.
Peglntron™
Peglntron™, peginterferon alfa-2b, Powder for Injection is a covalent
conjugate of recombinant human alfa-2b interferon with monomethoxy polyethylene
glycol (PEG). The average molecular weight of the PEG portion of the molecule
is 12,000 daltons. The average molecular weight of the Peglntron™ molecule
is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b
is approximately 0.7 x108 IU/mg protein.
Interferon alfa-2b, is a water-soluble protein with a molecular weight of 19,271
daltons produced by recombinant DNA techniques. It is obtained from the bacterial
fermentation of a strain of Escherichia coli bearing a genetically engineered
plasmid containing an interferon gene from human leukocytes.
REDIPEN®
REDIPEN® is a dual-chamber glass cartridge containing lyophilized Peglntron™
as a white to off-white tablet or powder that is whole or in pieces in the sterile
active chamber and a second chamber containing Sterile Water for Injection,
USP. Each Peglntron™ REDIPEN® contains either 67.5 mcg, 108 mcg, 162
mcg, or 202.5 mcg of Peglntron™, and 1.013 mg dibasic sodium phosphate
anhydrous, 1.013 mg monobasic sodium phosphate dihydrate, 54 mg sucrose and
0.0675 mg polysorbate 80. Each cartridge is reconstituted to allow for the administration
of up to 0.5 mL of solution. Following reconstitution, each REDIPEN® contains
Peglntron™ at strengths of either 50 mcg per 0.5 mL, 80 mcg per 0.5 mL,
120 mcg per 0.5 mL or 150 mcg per 0.5 mL for a single use. Because a small volume
of reconstituted solution is lost during preparation of Peglntron™, each
REDIPEN® contains an excess amount of Peglntron™ powder and diluent
to ensure delivery of the labeled dose.
REBETOL®
REBETOL® is Schering Corporation's brand name for ribavirin, a nucleoside
analog. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-
carboxamide and has the following structural formula:








Ribavirin is a white, crystalline powder. It is freely soluble in water and
slightly soluble in anhydrous alcohol. The empirical formula is C8H12N405
and the molecular weight is 244.21.
REBETOL® Capsules consist of a white powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The capsule shell consists of gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide. The capsule is printed with edible blue pharmaceutical ink which is made of shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, and FD&C Blue #2 aluminum lake.
Last reviewed on RxList: 2/24/2009




PegIntron, Rebetol Combo Pack Drug Description
Peglntron™ REDIPEN® Single-dose Delivery System
(peginterferon alfa-2b) and
REBETOL®
(ribavirin, USP) Capsules

Significant teratogenic and/or embryocidal effects have been demonstrated
in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose
half-life of 12 days, and so it may persist in nonplasma compartments for
as long as 6 months. Therefore, REBETOL® therapy is contraindicated in
women who are pregnant and in the male partners of women who are pregnant.
Extreme care must be taken to avoid pregnancy during therapy and for 6 months
after completion of treatment in both female patients and in female partners
of male patients who are taking REBETOL® therapy. At least two reliable
forms of effective contraception must be utilized during treatment and during
the 6-month posttreatment follow-up period. (See CONTRAINDICATIONS,
WARNINGS, PRECAUTIONS -
lnformation for Patients and Pregnancy
Category X.)
The primary toxicity of ribavirin is hemolytic anemia. The anemia associated
with REBETOL® therapy may result in a worsening of cardiac disease that
has led to fatal and nonfatal myocardial infarctions. Patients with a history
of significant or unstable cardiac disease should not be treated with REBETOL®.
(See WARNINGS, ADVERSE
REACTIONS, and DOSAGE AND ADMINISTRATION.) Alpha interferons, including Peglntron™, may cause or aggravate fatal
or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious
disorders. Patients should be monitored closely with periodic clinical and
laboratory evaluations. Patients with persistently severe or worsening signs
or symptoms of these conditions should be withdrawn from therapy. In many
but not all cases these disorders resolve after stopping Peglntron™
therapy. (See WARNINGS, ADVERSE
REACTIONS.)

DRUG DESCRIPTION
Peglntron™/REBETOL® Combo Pack contains Peglntron™ REDIPEN® Single-dose Delivery System (peginterferon alfa-2b) and REBETOL® (ribavirin) capsules.
Peglntron™
Peglntron™, peginterferon alfa-2b, Powder for Injection is a covalent
conjugate of recombinant human alfa-2b interferon with monomethoxy polyethylene
glycol (PEG). The average molecular weight of the PEG portion of the molecule
is 12,000 daltons. The average molecular weight of the Peglntron™ molecule
is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b
is approximately 0.7 x108 IU/mg protein.
Interferon alfa-2b, is a water-soluble protein with a molecular weight of 19,271
daltons produced by recombinant DNA techniques. It is obtained from the bacterial
fermentation of a strain of Escherichia coli bearing a genetically engineered
plasmid containing an interferon gene from human leukocytes.
REDIPEN®
REDIPEN® is a dual-chamber glass cartridge containing lyophilized Peglntron™
as a white to off-white tablet or powder that is whole or in pieces in the sterile
active chamber and a second chamber containing Sterile Water for Injection,
USP. Each Peglntron™ REDIPEN® contains either 67.5 mcg, 108 mcg, 162
mcg, or 202.5 mcg of Peglntron™, and 1.013 mg dibasic sodium phosphate
anhydrous, 1.013 mg monobasic sodium phosphate dihydrate, 54 mg sucrose and
0.0675 mg polysorbate 80. Each cartridge is reconstituted to allow for the administration
of up to 0.5 mL of solution. Following reconstitution, each REDIPEN® contains
Peglntron™ at strengths of either 50 mcg per 0.5 mL, 80 mcg per 0.5 mL,
120 mcg per 0.5 mL or 150 mcg per 0.5 mL for a single use. Because a small volume
of reconstituted solution is lost during preparation of Peglntron™, each
REDIPEN® contains an excess amount of Peglntron™ powder and diluent
to ensure delivery of the labeled dose.
REBETOL®
REBETOL® is Schering Corporation's brand name for ribavirin, a nucleoside
analog. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-
carboxamide and has the following structural formula:








Ribavirin is a white, crystalline powder. It is freely soluble in water and
slightly soluble in anhydrous alcohol. The empirical formula is C8H12N405
and the molecular weight is 244.21.
REBETOL® Capsules consist of a white powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The capsule shell consists of gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide. The capsule is printed with edible blue pharmaceutical ink which is made of shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, and FD&C Blue #2 aluminum lake.
Last reviewed on RxList: 2/24/2009




PegIntron, Rebetol Combo Pack Drug Description
Peglntron™ REDIPEN® Single-dose Delivery System
(peginterferon alfa-2b) and
REBETOL®
(ribavirin, USP) Capsules

Significant teratogenic and/or embryocidal effects have been demonstrated
in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose
half-life of 12 days, and so it may persist in nonplasma compartments for
as long as 6 months. Therefore, REBETOL® therapy is contraindicated in
women who are pregnant and in the male partners of women who are pregnant.
Extreme care must be taken to avoid pregnancy during therapy and for 6 months
after completion of treatment in both female patients and in female partners
of male patients who are taking REBETOL® therapy. At least two reliable
forms of effective contraception must be utilized during treatment and during
the 6-month posttreatment follow-up period. (See CONTRAINDICATIONS,
WARNINGS, PRECAUTIONS -
lnformation for Patients and Pregnancy
Category X.)
The primary toxicity of ribavirin is hemolytic anemia. The anemia associated
with REBETOL® therapy may result in a worsening of cardiac disease that
has led to fatal and nonfatal myocardial infarctions. Patients with a history
of significant or unstable cardiac disease should not be treated with REBETOL®.
(See WARNINGS, ADVERSE
REACTIONS, and DOSAGE AND ADMINISTRATION.) Alpha interferons, including Peglntron™, may cause or aggravate fatal
or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious
disorders. Patients should be monitored closely with periodic clinical and
laboratory evaluations. Patients with persistently severe or worsening signs
or symptoms of these conditions should be withdrawn from therapy. In many
but not all cases these disorders resolve after stopping Peglntron™
therapy. (See WARNINGS, ADVERSE
REACTIONS.)

DRUG DESCRIPTION
Peglntron™/REBETOL® Combo Pack contains Peglntron™ REDIPEN® Single-dose Delivery System (peginterferon alfa-2b) and REBETOL® (ribavirin) capsules.
Peglntron™
Peglntron™, peginterferon alfa-2b, Powder for Injection is a covalent
conjugate of recombinant human alfa-2b interferon with monomethoxy polyethylene
glycol (PEG). The average molecular weight of the PEG portion of the molecule
is 12,000 daltons. The average molecular weight of the Peglntron™ molecule
is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b
is approximately 0.7 x108 IU/mg protein.
Interferon alfa-2b, is a water-soluble protein with a molecular weight of 19,271
daltons produced by recombinant DNA techniques. It is obtained from the bacterial
fermentation of a strain of Escherichia coli bearing a genetically engineered
plasmid containing an interferon gene from human leukocytes.
REDIPEN®
REDIPEN® is a dual-chamber glass cartridge containing lyophilized Peglntron™
as a white to off-white tablet or powder that is whole or in pieces in the sterile
active chamber and a second chamber containing Sterile Water for Injection,
USP. Each Peglntron™ REDIPEN® contains either 67.5 mcg, 108 mcg, 162
mcg, or 202.5 mcg of Peglntron™, and 1.013 mg dibasic sodium phosphate
anhydrous, 1.013 mg monobasic sodium phosphate dihydrate, 54 mg sucrose and
0.0675 mg polysorbate 80. Each cartridge is reconstituted to allow for the administration
of up to 0.5 mL of solution. Following reconstitution, each REDIPEN® contains
Peglntron™ at strengths of either 50 mcg per 0.5 mL, 80 mcg per 0.5 mL,
120 mcg per 0.5 mL or 150 mcg per 0.5 mL for a single use. Because a small volume
of reconstituted solution is lost during preparation of Peglntron™, each
REDIPEN® contains an excess amount of Peglntron™ powder and diluent
to ensure delivery of the labeled dose.
REBETOL®
REBETOL® is Schering Corporation's brand name for ribavirin, a nucleoside
analog. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-
carboxamide and has the following structural formula:








Ribavirin is a white, crystalline powder. It is freely soluble in water and
slightly soluble in anhydrous alcohol. The empirical formula is C8H12N405
and the molecular weight is 244.21.
REBETOL® Capsules consist of a white powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The capsule shell consists of gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide. The capsule is printed with edible blue pharmaceutical ink which is made of shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, and FD&C Blue #2 aluminum lake.
Last reviewed on RxList: 2/24/2009




PegIntron, Rebetol Combo Pack Drug Description
Peglntron™ REDIPEN® Single-dose Delivery System
(peginterferon alfa-2b) and
REBETOL®
(ribavirin, USP) Capsules

Significant teratogenic and/or embryocidal effects have been demonstrated
in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose
half-life of 12 days, and so it may persist in nonplasma compartments for
as long as 6 months. Therefore, REBETOL® therapy is contraindicated in
women who are pregnant and in the male partners of women who are pregnant.
Extreme care must be taken to avoid pregnancy during therapy and for 6 months
after completion of treatment in both female patients and in female partners
of male patients who are taking REBETOL® therapy. At least two reliable
forms of effective contraception must be utilized during treatment and during
the 6-month posttreatment follow-up period. (See CONTRAINDICATIONS,
WARNINGS, PRECAUTIONS -
lnformation for Patients and Pregnancy
Category X.)
The primary toxicity of ribavirin is hemolytic anemia. The anemia associated
with REBETOL® therapy may result in a worsening of cardiac disease that
has led to fatal and nonfatal myocardial infarctions. Patients with a history
of significant or unstable cardiac disease should not be treated with REBETOL®.
(See WARNINGS, ADVERSE
REACTIONS, and DOSAGE AND ADMINISTRATION.) Alpha interferons, including Peglntron™, may cause or aggravate fatal
or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious
disorders. Patients should be monitored closely with periodic clinical and
laboratory evaluations. Patients with persistently severe or worsening signs
or symptoms of these conditions should be withdrawn from therapy. In many
but not all cases these disorders resolve after stopping Peglntron™
therapy. (See WARNINGS, ADVERSE
REACTIONS.)

DRUG DESCRIPTION
Peglntron™/REBETOL® Combo Pack contains Peglntron™ REDIPEN® Single-dose Delivery System (peginterferon alfa-2b) and REBETOL® (ribavirin) capsules.
Peglntron™
Peglntron™, peginterferon alfa-2b, Powder for Injection is a covalent
conjugate of recombinant human alfa-2b interferon with monomethoxy polyethylene
glycol (PEG). The average molecular weight of the PEG portion of the molecule
is 12,000 daltons. The average molecular weight of the Peglntron™ molecule
is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b
is approximately 0.7 x108 IU/mg protein.
Interferon alfa-2b, is a water-soluble protein with a molecular weight of 19,271
daltons produced by recombinant DNA techniques. It is obtained from the bacterial
fermentation of a strain of Escherichia coli bearing a genetically engineered
plasmid containing an interferon gene from human leukocytes.
REDIPEN®
REDIPEN® is a dual-chamber glass cartridge containing lyophilized Peglntron™
as a white to off-white tablet or powder that is whole or in pieces in the sterile
active chamber and a second chamber containing Sterile Water for Injection,
USP. Each Peglntron™ REDIPEN® contains either 67.5 mcg, 108 mcg, 162
mcg, or 202.5 mcg of Peglntron™, and 1.013 mg dibasic sodium phosphate
anhydrous, 1.013 mg monobasic sodium phosphate dihydrate, 54 mg sucrose and
0.0675 mg polysorbate 80. Each cartridge is reconstituted to allow for the administration
of up to 0.5 mL of solution. Following reconstitution, each REDIPEN® contains
Peglntron™ at strengths of either 50 mcg per 0.5 mL, 80 mcg per 0.5 mL,
120 mcg per 0.5 mL or 150 mcg per 0.5 mL for a single use. Because a small volume
of reconstituted solution is lost during preparation of Peglntron™, each
REDIPEN® contains an excess amount of Peglntron™ powder and diluent
to ensure delivery of the labeled dose.
REBETOL®
REBETOL® is Schering Corporation's brand name for ribavirin, a nucleoside
analog. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-
carboxamide and has the following structural formula:








Ribavirin is a white, crystalline powder. It is freely soluble in water and
slightly soluble in anhydrous alcohol. The empirical formula is C8H12N405
and the molecular weight is 244.21.
REBETOL® Capsules consist of a white powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The capsule shell consists of gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide. The capsule is printed with edible blue pharmaceutical ink which is made of shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, and FD&C Blue #2 aluminum lake.
Last reviewed on RxList: 2/24/2009




PegIntron, Rebetol Combo Pack Drug Description
Peglntron™ REDIPEN® Single-dose Delivery System
(peginterferon alfa-2b) and
REBETOL®
(ribavirin, USP) Capsules

Significant teratogenic and/or embryocidal effects have been demonstrated
in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose
half-life of 12 days, and so it may persist in nonplasma compartments for
as long as 6 months. Therefore, REBETOL® therapy is contraindicated in
women who are pregnant and in the male partners of women who are pregnant.
Extreme care must be taken to avoid pregnancy during therapy and for 6 months
after completion of treatment in both female patients and in female partners
of male patients who are taking REBETOL® therapy. At least two reliable
forms of effective contraception must be utilized during treatment and during
the 6-month posttreatment follow-up period. (See CONTRAINDICATIONS,
WARNINGS, PRECAUTIONS -
lnformation for Patients and Pregnancy
Category X.)
The primary toxicity of ribavirin is hemolytic anemia. The anemia associated
with REBETOL® therapy may result in a worsening of cardiac disease that
has led to fatal and nonfatal myocardial infarctions. Patients with a history
of significant or unstable cardiac disease should not be treated with REBETOL®.
(See WARNINGS, ADVERSE
REACTIONS, and DOSAGE AND ADMINISTRATION.) Alpha interferons, including Peglntron™, may cause or aggravate fatal
or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious
disorders. Patients should be monitored closely with periodic clinical and
laboratory evaluations. Patients with persistently severe or worsening signs
or symptoms of these conditions should be withdrawn from therapy. In many
but not all cases these disorders resolve after stopping Peglntron™
therapy. (See WARNINGS, ADVERSE
REACTIONS.)

DRUG DESCRIPTION
Peglntron™/REBETOL® Combo Pack contains Peglntron™ REDIPEN® Single-dose Delivery System (peginterferon alfa-2b) and REBETOL® (ribavirin) capsules.
Peglntron™
Peglntron™, peginterferon alfa-2b, Powder for Injection is a covalent
conjugate of recombinant human alfa-2b interferon with monomethoxy polyethylene
glycol (PEG). The average molecular weight of the PEG portion of the molecule
is 12,000 daltons. The average molecular weight of the Peglntron™ molecule
is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b
is approximately 0.7 x108 IU/mg protein.
Interferon alfa-2b, is a water-soluble protein with a molecular weight of 19,271
daltons produced by recombinant DNA techniques. It is obtained from the bacterial
fermentation of a strain of Escherichia coli bearing a genetically engineered
plasmid containing an interferon gene from human leukocytes.
REDIPEN®
REDIPEN® is a dual-chamber glass cartridge containing lyophilized Peglntron™
as a white to off-white tablet or powder that is whole or in pieces in the sterile
active chamber and a second chamber containing Sterile Water for Injection,
USP. Each Peglntron™ REDIPEN® contains either 67.5 mcg, 108 mcg, 162
mcg, or 202.5 mcg of Peglntron™, and 1.013 mg dibasic sodium phosphate
anhydrous, 1.013 mg monobasic sodium phosphate dihydrate, 54 mg sucrose and
0.0675 mg polysorbate 80. Each cartridge is reconstituted to allow for the administration
of up to 0.5 mL of solution. Following reconstitution, each REDIPEN® contains
Peglntron™ at strengths of either 50 mcg per 0.5 mL, 80 mcg per 0.5 mL,
120 mcg per 0.5 mL or 150 mcg per 0.5 mL for a single use. Because a small volume
of reconstituted solution is lost during preparation of Peglntron™, each
REDIPEN® contains an excess amount of Peglntron™ powder and diluent
to ensure delivery of the labeled dose.
REBETOL®
REBETOL® is Schering Corporation's brand name for ribavirin, a nucleoside
analog. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-
carboxamide and has the following structural formula:








Ribavirin is a white, crystalline powder. It is freely soluble in water and
slightly soluble in anhydrous alcohol. The empirical formula is C8H12N405
and the molecular weight is 244.21.
REBETOL® Capsules consist of a white powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The capsule shell consists of gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide. The capsule is printed with edible blue pharmaceutical ink which is made of shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, and FD&C Blue #2 aluminum lake.
Last reviewed on RxList: 2/24/2009





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